18 results · 21ms · Sources: EU EUDAMED, US FDA

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BRILLIANT Crios

FDA 510(k)
FDA Class 2 ·Dental

Lateral Patient Positioning System

FDA UDI
ALPHATEC SPINE, INC.·00190376484235·Arm Board

Ophthalmic Retractor

FDA UDI
KATENA PRODUCTS, INC.·00841668101025·JAEGER LID PLATE PLASTIC

Life Instruments

FDA UDI
Life Instrument Corporation·M930718150000·Down Pushing Curete #0

Origin Hip Stem

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215051518·

Origin

FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215001438·

Paxeon Origin

FDA UDI
PAXEON RECONSTRUCTION LLC·08177570200580·Origin Stem, Standard Offset Size 15

OrthoMedFlex

FDA UDI
ORTHOMEDFLEX LLC·M7161111815000·Origin Hip Stem, Standard Offset Collarless, Ce...

Echotip

FDA UDI
COOK INCORPORATED·00827002163485·Echotip Disposable Mennuti Sampling Needle Set

OPTIO-C ANTERIOR CERVICAL SYSTEM

FDA 510(k)
FDA Class 2 ·Orthopedic

YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS

FDA 510(k)
FDA Class 2 ·Neurology

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 11, 2025

STRATUS Stem

FDA UDI
AMPLITUDE SAS·03701089521208·

CALLCORD,18",1500,MECH.,E-Z CARE WIRING

FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828160254·CALLCORD,18",1500,MECH.,E-Z CARE WIRING

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

HOMECHOICE

FDA Adverse Event
Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 21, 2013

9800

FDA Adverse Event
Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 7, 2011

Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

FDA Enforcement
Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014